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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Coagulation Factor VIIa (Recombinant)
Date Designated: 10/03/2006
Orphan Designation: Treatment of bleeding in patients experiencing intracranial hemorrhage.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/20/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novo Nordisk, Inc.
P. O. Box 846
Plainsboro, New Jersey 08536
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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